Senior Associate Quality Control

Amgen • Thousand Oaks, CA

1d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Associate Quality Control What you will do Let’s do this. Let’s change the world. In this vital role you will support the QC Immunoassay and General Testing team by performing testing and data review/approval for ELISA methodology assays, qPCR, Karl Fisher Moisture, BLE (Break loose and Extrusion) and UV Spectroscopy. Staff member may also perform additional testing such as Viscosity, Osmolality and Reconstitution Time.

Requirements

• High school/GED + 4 years of Quality Control experience OR
• Associate’s + 2 years of Quality Control experience OR
• Bachelor’s + 6 months of Quality Control experience

Nice To Haves

• cGMP Experience
• Experience in Immunoassay (ELISA methodology)
• Experience using LIMS and/or SmartLab
• Experience and knowledge of Method Transfer and Validation Process
• Experience and knowledge of Data Integrity Requirements of QC Systems
• Proficient in Microsoft Office (e.g. Outlook, Word, Excel, PowerPoint)
• Excellent problem-solving capabilities and attention to detail
• Experience of collaboration within and across functional areas and outstanding customer service focus
• Excellent written and verbal communication skills

Responsibilities

• Report, evaluate, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with partners.
• Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook.
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
• Implement protocols and perform assay transfer/validation and equipment qualification/verification.
• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
• Participate in lab investigations.
• Provide technical guidance.
• Provide training to others.
• May represent the department/organization on various teams
• May interact with outside resources

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level